MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	B2120-040
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.H6: device code 2017 - above rated burst pressure.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a tight atrioventricular (av) fistula.The 12x40mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced without resistance and inflated 6 times to 14 atmospheres and ruptured.When the balloon ruptured, it became entangled with an unspecified guide wire.The guide wire and the balloon were retracted to the sheath and could not be withdrawn from the sheath so all was removed together except for 8 inches of guide wire.The guide wire was then cut in order to remove the balloon.There was significant access site pain.
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the lot number was not reported.It should be noted that the rate of burst pressure (rbp) for a 12x40mm armada 35 is 10 atmospheres.The armada 35 instruction for use (ifu) warns: inflation in excess of the rated burst pressure may cause the balloon to rupture.The investigation determined that the reported difficulties were likely user related.It is likely that the rupture occurred due to inflating the balloon multiple times above the rated burst pressure (rbp).The difficulty removing was likely the result of the ruptured balloon material interacting with the guide wire and introducer sheath during removal, resulting in pain at the access site.The reported patient effect of pain is listed is listed in the armada 35 ifu as a known potential complication associated with the use of the device.There is no indication of a product quality issue with respect to manufacture, design or labeling.Device return status updated from yes to no.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9261755
• Report Number: 2024168-2019-13088
• Device Sequence Number: 17076313
• Product Code: LIT
• UDI-Device Identifier: 08717648155550
• UDI-Public: 08717648155550
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: B2120-040
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Weight: 75